Swissmedic Annual Report 2017: achieving success through collaboration

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42 Market access l Inspections GCP and GVP inspections Swissmedic inspects clinical trials of medicinal products conducted in Switzerland by sponsors, contract research organisations, trial centres, facilities and laboratories on a random basis according to defined risk criteria to assess compliance with the relevant Swiss legislation, the rules of Good Clinical Practice (GCP) and other international guidelines on the implementation of clinical trials. The inspections focus on whether the safety and personal rights of trial participants are guaranteed. They also verify whether the trials are being conducted in accordance with the scientific criteria for quality and integrity. Pharmacovigilance inspections (Good Vigilance Practice, GVP) are above all designed to examine compliance with the legally prescribed mandatory reporting of adverse drug reactions in clinical trials as well as spontaneous reports. Activities • During 2017, Swissmedic conducted 30 GCP inspections in connection with clinical trials of medicinal products in Switzerland. • Swissmedic also carried out 11 GVP inspections in Switzerland. • Within the framework of the Geneva-based PIC / S (Pharmaceutical Inspections Cooperation Scheme) convention, Swissmedic participated in one programme of GCP inspections and one programme of GVP inspections. In this context, Swissmedic accompanied one GVP inspection carried out by foreign authorities in Lithuania. One of the 30 GCP inspections conducted in Switzerland was also part of the PIC/S programme. • On the other hand, Swissmedic provided specialist support during GCP inspections conducted in Switzerland by the EMA, FDA and BfArM. • In 2017, Swissmedic’s GCP / GVP inspectors again participated in the EMA’s Inspectors Working Groups. • One inspection relating to a clinical trial with a transplant product was conducted in 2017. Performance indicator 100 % 153 % GCP / GVP inspections; degree to which the annual plan was fulfilled Target Result
Market access l Inspections 43 GLP inspections Inspections for third parties With the exception of pharmacodynamics for notification or authorisation procedures, non-clinical assessments for authorisation in Switzerland are to be carried out in accordance with Good Laboratory Practice (GLP). Swissmedic’s GLP unit carries out monitoring activities (inspections or study audits) with the relevant divisions of the Federal Office for the Environment (FOEN) and the Federal Office of Public Health (FOPH) within the framework of the GLP monitoring programme. Additional requirements imposed by US or European authorities, such as the FDA‘s requirements for medical devices, are also taken into account. Activities • The number of test facilities continued to decline in 2017. A further three test facilities withdrew from the GLP monitoring programme at their own request, necessitating a reorganisation within Swissmedic’s GLP unit. In future, monitoring activities will be in the hands of four, instead of the current eight, individuals. This will ensure that the quality of GLP inspections remains high with an adequate number of routine inspections. As a further measure, cooperation with the other GLP units at the FOPH and FOEN is being stepped up. • A total of six inspections was carried out. • Internationally, the Swiss monitoring programme was represented in the GLP Working Groups of the EU Commission and the OECD. Swissmedic can provide services for third parties, for which a fee is applied. For the Federal Office of Public Health (FOPH), Swissmedic carries out inspections and other implementation tasks in the fields of transplants and genetic tests on humans. Swissmedic also carries out some of the inspection activities in the therapeutic products sector for the Principality of Liechtenstein. Activities • In 2017, Swissmedic carried out 15 inspection procedures for the FOPH and two for the Principality of Liechtenstein. • Following the revision of the Transplantation Ordinance, the legislator has now assigned the extended oversight of activities involving tissues and cells for autologous transplantation to Swissmedic. Until the revised Ordinance came into force in November 2017, Swissmedic carried out inspections relating to autologous transplants on behalf of the FOPH. Performance indicator 100 % 100 % GLP inspections; degree to which the annual plan was fulfilled Target Result
Page 1 and 2: Annual Report 2017
Page 3 and 4: 3 Contents Foreword by Christine Be
Page 5 and 6: 5 Standards Legal matters 64 Legisl
Page 7 and 8: 7 Jürg H. Schnetzer Transposing th
Page 9 and 10: 9 Raimund Bruhin Mr Bruhin, you too
Page 11 and 12: 11 Improved public access to medici
Page 13 and 14: 13 This is an attractive process fo
Page 15 and 16: 15 Key issues in 2017 Increased saf
Page 17 and 18: 17 Entry into force of the revised
Page 19 and 20: 19 Number of authorisations by disp
Page 21 and 22: 21 Authorisation of human medicinal
Page 23 and 24: Market access | Marketing authorisa
Page 27 and 28: 27 Applications under Article 13 TP
Page 33 and 34: 33 Variations requiring approval an
Page 37 and 38: Market access | Licensing 37 Licens
Page 39 and 40: Market access | Licensing 39 Import
Page 41: Market access l Inspections 41 Insp
Page 45 and 46: Market access | Licensing 45 Licens
Page 47 and 48: 47 Analysis conclusions for new mar
Page 49 and 50: Market access | Medicinal products
Page 53 and 54: 53 Risk mitigation measures It is m
Page 59 and 60: Market access | Medical devices 59
Page 61 and 62: Market access | Medical devices 61
Page 63 and 64: 63 Special activities and events: M
Page 65 and 66: Standards 65 Pharmacopoeia The phar
Page 67: Penal law 67 Investigative measures
Page 70 and 71: 70 Stakeholder management Stakehold
Page 72 and 73: 72 Stakeholder management Publicati
Page 74 and 75: 74 Stakeholder management Transpare
Page 76 and 77: 76 Stakeholder management External
Page 78 and 79: 78 Stakeholder management • Swiss
Page 80 and 81: 80 Telematics / Information Telemat
Page 82 and 83: 82 Corporate Governance Organisatio
Page 84 and 85: 84 Corporate Governance Revenues Sw
Page 86 and 87: 86 Corporate Governance Management
Page 88 and 89: 88 Organisation Organisation Swissm
Page 90 and 91: 90 Organisation Our staff - our cap
Page 92 and 93:
92 Income statement Income statemen
Page 94 and 95:
94 Products funded mainly by the Co
Page 96:
Schweizerisches Heilmittelinstitut
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